Principles and Practice of Pharmaceutical Medicine

gray, which represents low disproportionality, that
is the observed frequency is not substantially dif-
ferent from the expected, while the darker gray
represents AE–drug combinations with higher
measures of disproportionality.

Interpretation

Figures 40.2–40.5 show the frequency and EB05
scores, both total and cumulative by year, of rhab-

domyolysis associated with the use of the statins.

Although all the statins have an EB052 for rhab-

domyolysis, and this is a well-recognized AE asso-

ciated with the use of statins, both the frequency

(5280) and the EB05 (10.93) noted with cerivastatin

are significantly higher than any of the other statins.

This clearly suggests an association between ceri-

vastatin and rhabdomyolysis that required further

investigation, with possible regulatory action.

The clinical importance of these observa-

tions could have been explored through other

Figure 40.2 The number of cases of rhabdomyolysis in the AERS database associated with the statins

Figure 40.3 The disproportionality score (EB05) of cases of rhabdomyolysis in the AERS database associated with
the statins

550 CH40 DATA MINING